Effects of Stevia on Satiety and Eating Attitudes in Healthy, Overweight and Obese Adults

This study has been completed.
Sponsor:
Information provided by:
Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01115088
First received: April 29, 2010
Last updated: May 3, 2010
Last verified: April 2010
  Purpose

The purpose of this study is to test the effects that three different types of sweeteners have on food intake, hunger and satiety levels, as well as insulin and glucose measures. The study of whether food or beverages containing Stevia influence food intake to a greater extent than food or beverages sweetened with Aspartame or Sucrose. Also, examining whether taste preference and taste sensitivity influence food intake.


Condition Intervention
Obesity
Type 2 Diabetes
Dietary Supplement: Aspartame
Dietary Supplement: Sucrose
Dietary Supplement: Stevia

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Official Title: Effects of Stevia on Satiety and Eating Attitudes in Healthy, Overweight and Obese Adults: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Effects of stevia, aspartame, and sucrose on food intake, satiety, and postprandial glucose and insulin levels. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Test whether preloads of tea and crackers with cream cheese sweetened with Stevia lover postprandial insulin levels compared to preloads of tea and crackers with cream cheese sweetened with Sucrose or Aspartame by measuring blood insulin and glucose levels immediately prior to the lunch preload,immediately before lunch test meal, and at thirty minutes, one hour, and two hours after the lunch test meal.


Secondary Outcome Measures:
  • Hedonic ratings (appearance, aroma, flavor, texture and palatability)with Stevia sweetener compared to Sucrose or Aspartame [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Test whether preloads of tea and crackers with cream cheese sweetened with Stevia have different hedonic ratings compared to preloads of tea and crackers with cream cheese sweetened with Sucrose or Aspartame by examining hunger and satiety ratings after the preload.

  • Satiating effects by examining food consumption [ Time Frame: 24 Hours ] [ Designated as safety issue: No ]
    Test whether preloads of tea and crackers with cream cheese sweetened with stevia have different satiating effects compared to preloads of tea and crackers with cream cheese sweetened with Sucrose or Aspartame by examining food consumption 20 minutes and after lunch and dinner preloads, as well as total food consumption.


Enrollment: 30
Study Start Date: January 2006
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aspartame
Food or beverages containing Aspartame in comparison to Stevia or Sucrose
Dietary Supplement: Aspartame
The morning breakfast after a 12-h fast and consumed a standard 469 kcal breakfast consisting of cereal, milk, toast with butter, and orange juice. Tea and crackers with cream cheese sweetened with stevia Whole Foods 365 Brand, aspartame equal sweetener, or sucrose participants consumed this preload 20 min before their test lunch and dinner meals. The Test lunch meal consisted of sandwiches, potato chips, and cookies, and the test dinner meal was a self-selected buffet-type meal (I.e., Macronutrient Self-Selection Paradigm) Geiselman et al,. 1998)
Other Name: equal sweetener
Experimental: Sucrose
Food or beverages containing Sucrose in comparison to Aspartame or Stevia
Dietary Supplement: Sucrose
The morning breakfast after a 12-h fast and consumed a standard 469 kcal breakfast consisting of cereal, milk, toast with butter, and orange juice. Tea and crackers with cream cheese sweetened with stevia Whole Foods 365 Brand, aspartame equal sweetener, or sucrose participants consumed this preload 20 min before their test lunch and dinner meals. The Test lunch meal consisted of sandwiches, potato chips, and cookies, and the test dinner meal was a self-selected buffet-type meal (I.e., Macronutrient Self-Selection Paradigm) Geiselman et al,. 1998)
Experimental: Stevia
Food or beverages containing Stevia in comparison to Aspartame or Sucrose
Dietary Supplement: Stevia
The morning breakfast after a 12-h fast and consumed a standard 469 kcal breakfast consisting of cereal, milk, toast with butter, and orange juice. Tea and crackers with cream cheese sweetened with stevia Whole Foods 365 Brand, aspartame equal sweetener, or sucrose participants consumed this preload 20 min before their test lunch and dinner meals. The Test lunch meal consisted of sandwiches, potato chips, and cookies, and the test dinner meal was a self-selected buffet-type meal (I.e., Macronutrient Self-Selection Paradigm) Geiselman et al,. 1998)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy and have a body mass index > 30 kg/m2 and < 39.9 kg/m2, or have a body mass index > 20 kg/m2 and < 24.9 kg/m2
  • If BMI is between 30 and 39.9, waist circumference must be > 36 for women and > 40 for men.
  • Age 18 to 45 years
  • Nonsmokers
  • Willing to consume meat products
  • Women on monophasic oral contraceptives or who have physiologically controlled cycles

Exclusion Criteria:

  • A history of diabetes, cardiovascular disease, or other chronic illnesses
  • Presence of an eating disorder including Anorexia and/or Bulimia Nervosa
  • Other health problems that might interfere with your ability to participate in the study
  • Taking medications, other than monophasic birth control or monophasic (same dose every day) hormone replacement therapy and allergy medication
  • Taking allergy medication for a period of time less than 6 months
  • Dislike of or allergy to foods/sweeteners (Sucrose, Stevia, or Aspartame) used in test meals
  • Smokers
  • High scores on the Dietary Restraint, Disinhibition, and Perceived Hunger scales of the Three Factor Eating Questionnaire
  • Use of oral contraceptives other than monophasic (same dose every day) contraceptives
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01115088

Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Investigators
Principal Investigator: Stephen D. Anton, PhD Pennington Biomedical Research Center
  More Information

No publications provided

Responsible Party: Stephen Anton PhD / Principle Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01115088     History of Changes
Other Study ID Numbers: PBRC25030
Study First Received: April 29, 2010
Last Updated: May 3, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Obesity
Overweight
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 08, 2014